Clinical Research Regulatory Specialist B
About The Position
The Penn Neurogenetics Therapy Center (PNTC) supports a diverse group of neurogenetics investigators and clinical research professionals conducting investigator-initiated clinical research and complex, industry-sponsored, first-in-human trials of gene therapies for neurological diseases. The PNTC is seeking a Clinical Research Regulatory Specialist B (CRRS B) to support clinical trial startup and ongoing regulatory activities across the Center’s portfolio of clinical trials while following applicable institutional and federal regulations as well as ICH-GCP guidelines. The CRRS B will function as part of a multidisciplinary team and will report to the PNTC Director of Operations. The CRRS B will play a key role in coordinating trial start-up activities from feasibility assessment through site activation, working closely with PNTC Project and Business Managers, investigators, study teams, institutional offices, sponsors, and contract research organizations (CROs). Responsibilities will include coordinating and tracking regulatory and ancillary submissions, essential study documentation, and other startup requirements to support efficient and timely study activation. Following activation, the CRRS B will collaborate with study teams to provide ongoing regulatory support, including protocol amendments, continuing reviews, reportable events, regulatory documentation, maintenance of complete and inspection-ready study files, and coordination of monitoring visits and audits. The ideal candidate will be highly motivated, organized, and detail-oriented, with a proactive and collaborative approach and the ability to plan and manage multiple priorities and deadlines in a fast-paced clinical research environment. Prior experience with regulatory/ethics boards/ancillary submissions and reviews, industry-sponsored early-phase clinical trials, and/or gene therapy research is strongly preferred.
Requirements
- Bachelor's degree and 3-5 years of research experience or equivalent combination of education and experience is required.
- At least 1 year of regulatory experience preferred.
- Associated research credentialing (RAC, CCRP, CIP, etc.) preferred.
- Must be organized and able to prioritize
- effective communication and writing skills
- strong time management skills
- flexible and able to multi-task
- demonstrated ability to work as part of a team, as well as independently.
Nice To Haves
- Prior experience with regulatory/ethics boards/ancillary submissions and reviews
- industry-sponsored early-phase clinical trials
- gene therapy research
Responsibilities
- Coordinate clinical trial startup from feasibility assessment through site activation, working collaboratively with PNTC Project and Business Managers and other stakeholders to track regulatory and ancillary submissions, essential study documentation, timelines, dependencies, outstanding items, and activation requirements across regulatory, operational, budget, and contract workflows.
- Prepare, coordinate, and process regulatory submissions to the IRB and required ancillary review committees, and prepare, collect, and submit essential regulatory documentation required by sponsors, CROs, and other applicable entities.
- Provide ongoing regulatory support for active clinical trials, including protocol amendments, continuing reviews, reportable events, personnel and study document updates, and other required regulatory submissions and documentation.
- Maintain complete, accurate, current, and inspection-ready regulatory documentation and investigator site files (ISFs) throughout the study lifecycle in accordance with institutional, sponsor, and applicable regulatory requirements.
- Resolve regulatory queries and support study oversight activities, including site initiation, monitoring, audit, inspection, and close-out activities, in collaboration with investigators and study teams.
- Participate in study team meetings, protocol and regulatory training, and compliance activities, and contribute to the development and continuous improvement of regulatory and clinical trial startup processes, guidance documents, templates, trackers, and other work tools.
- Perform additional duties as assigned.
Benefits
- excellent healthcare
- tuition benefits for employees and their families
- generous retirement benefits
- a wide variety of professional development opportunities
- supportive work and family benefits
- a wealth of health and wellness programs and resources
- Health, Life, and Flexible Spending Accounts
- Tuition assistance here at Penn for employee, spouse, and dependent children
- Tuition assistance at other institutions for dependent children
- generous retirement plans
- substantial amount of time away from work
- Long-Term Care Insurance
- Wellness and Work-life Resources
- Professional and Personal Development
- access to a wide range of University resources as well as cultural and recreational activities
- Discounts and Special Services
- Flexible Work Hours
- Penn Home Ownership Services
- Adoption Assistance
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
